表1

Summary of relevant licensed janus kinase inhibitors (JAKi) and thrombotic concerns

JAKi and selectivity Pharmaceutical company Licensed indication 指出君威rding thrombosis COVID-19 trials registered at ClinicalTrials.gov#
JAK 1/2, baricitinib Eli Lilly Rheumatoid arthritis
  • August 2017: SmPC revised to include a warning of reports of DVT and PE in patients receiving baricitinib and advised caution for use in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of these disorders, recent surgery or immobilisation

  • April 2018: FDA black box warning for DVT PE, 2 mg OD approved (not 4 mg OD), due to thrombotic concerns

NCT04340232
NCT04362943
NCT04346147
NCT04358614
NCT04390464
NCT04320277
NCT04373044
NCT04321993
NCT04345289
NCT04365764
NCT04366206
JAK 1/2, ruxolitinib Novartis Myelofibrosis
Polycythaemia
  • No safety alert for thrombosis

NCT04348071
NCT04355793
NCT04354714
NCT04362137
NCT04377620
NCT04334044
NCT04337359
NCT04331665
NCT04366232
NCT04374149
NCT04361903
NCT04338958
NCT04348695
NCT04359290
JAK 1/3, tofacitinib Pfizer Rheumatoid arthritis
Psoriatic arthritis
Ulcerative colitis
  • February 2019: FDA issued safety alert concerning thrombotic risk

  • July 2019: FDA black box warning for DVT and PE, for the 10 mg BD dose (this higher dose is approved for ulcerative colitis)

  • November 2019: EMA updated European product information with warning for thrombosis

NCT04390061
NCT04332042
JAK1, upadacitinib Abbvie Rheumatoid arthritis
  • August 2019: FDA black box warning for DVT, PE and arterial thrombosis

None
JAK2, fedratinib Celgene公司 Myelofibrosis
  • No safety alert for thrombosis

None

It is not clear whether the coronavirus disease 2019 (COVID-19) trials excluded patients at risk of thrombosis or mandated thromboprophylaxis. SmPC: summary of medicinal product characteristics; PE: pulmonary emboli; DVT: deep venous thrombosis; FDA: Food and Drug Administration; OD: once daily; BD twice daily: EMA: European Medicines Agency.#: n=27 as of 18 May 2020.